STAY SAFE HAND SANITIZER ALCOHOL FREE- benzalkonium chloride gel

Stay Safe Hand Sanitizer Alcohol Free by

Drug Labeling and Warnings

Stay Safe Hand Sanitizer Alcohol Free by is a Otc medication manufactured, distributed, or labeled by Denison Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Uses:

• For hand sanitizing to decrease bacteria and viruses on the skin
• Recommended for repeated use

Warnings

For external use only

When using this product avoid contact with eyes. In case of contact flush eyes with water.

Stop use or ask a doctor if irritation or redness develops or if condition persists for more than 72 hours

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

Pump a small amount of liquid into palm of hand Rub thoroughly over all surfaces on both hands for 15 seconds Rinse with potable water (Optional)

Other Information

Avoid excessive heat

Inactive Ingredients

Purified water, Aloe Vera Gel 10:1 Concentrate, Edetate Disodium Dihydrate USP, Igepal CO-630, Propylene Glycol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

STAY SAFE HAND SANITIZER ALCOHOL FREE 
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-9049
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
NONOXYNOL-9 (UNII: 48Q180SH9T)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0295-9049-23	177.441 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/27/2020

Labeler - Denison Pharmaceuticals, LLC (001207208)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, LLC		001207208	manufacture(0295-9049)